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EP3361253B1 - Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide - Google Patents

Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide Download PDF

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Publication number
EP3361253B1
EP3361253B1 EP17155143.5A EP17155143A EP3361253B1 EP 3361253 B1 EP3361253 B1 EP 3361253B1 EP 17155143 A EP17155143 A EP 17155143A EP 3361253 B1 EP3361253 B1 EP 3361253B1
Authority
EP
European Patent Office
Prior art keywords
sample
carrier
test strip
receptacle
carrier plate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP17155143.5A
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German (de)
English (en)
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EP3361253A1 (fr
Inventor
Christoph Protzek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Protzek Gesellschaft fur Biomedizinische Technik GmbH
Original Assignee
Protzek Gesellschaft fur Biomedizinische Technik GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Protzek Gesellschaft fur Biomedizinische Technik GmbH filed Critical Protzek Gesellschaft fur Biomedizinische Technik GmbH
Priority to EP17155143.5A priority Critical patent/EP3361253B1/fr
Priority to PCT/EP2018/050264 priority patent/WO2018145830A1/fr
Publication of EP3361253A1 publication Critical patent/EP3361253A1/fr
Application granted granted Critical
Publication of EP3361253B1 publication Critical patent/EP3361253B1/fr
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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
    • B01L3/5055—Hinged, e.g. opposable surfaces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/12—Specific details about materials
    • B01L2300/126—Paper

Definitions

  • the invention relates to a device for the targeted testing and display of the absence or presence of analytes in an originating from human or animal organism or other analysis or liquid sample according to the preamble of patent claim 1.
  • Devices for testing and indicating the presence or absence of analytes in a liquid sample e.g. of active ingredients such as drugs or drugs and their metabolites or biological substances as signs (markers) for certain diseases in a body fluid are known in different versions. These are usually running in a relatively short time analysis systems on an immunological or dry chemical basis, as well as DNA based (so-called aptamers). However, due to their functionality, these are not completely proof in the forensic sense.
  • the analytical principles consist of a more or less highly specific reaction to the possibly present analytes. This means that in rare, unpredictable cases, even previously unknown or unspecific interfering factors in a sample can cause a similar to comparable reaction.
  • the test cassette is designed to carry out a so-called "lateral flow” immunoassay and consists of a lower lid and an upper lid. Enclosed by these two lids, the test cassette contains a test strip which is held in place within a receptacle. In the upper lid is located above the sampler of the test strip, a filling opening through which a liquid sample can be entered. Above the middle test area of the test strip there is a control window through which the test result can be read.
  • the device comprises a carrier plate with test strip receptacles, in each of which a test strip provided with a sample receiving section and a test strip is arranged, and which is closed by a non-detachably connected to the carrier plate cover layer having a control window in the test sections of the test strips of the test strip recordings ,
  • the support plate is made of cardboard, wherein the film is formed of decomposable material, since such devices are environmentally friendly to dispose of.
  • the invention aims to remedy this situation.
  • the invention is based on the object to provide a device for targeted testing and display of the absence or presence of analytes in a liquid sample, which is simple in construction and in which a complex blood sampling is not required. According to the invention, this object is achieved by a device having the features of patent claim 1.
  • the invention provides a device for the targeted testing and display of the absence or presence of analytes in a liquid sample, which has a simple structure and which does not require the expensive blood sampling required in the prior art.
  • a sample liquid e.g., drops of blood
  • the defined dried liquid residues can then in the case of blood as so-called “dried blood spots” (DBS), in the case of urine as a so-called “dried urine spots” (DUS) or in the case of saliva as so-called “dries saliva spots” (DSS) etc., together with the test strips for confirmatory analysis.
  • DBS dried blood spots
  • DUS dried urine spots
  • DUS saliva spots
  • DUS saliva spots
  • DS analysis has long been established in the handling of microprobables. In analyzes for legal purposes, one particular advantage is that enzyme activities are the substances originally present build up or convert, are largely limited due to the rapid loss of their Hydrathülle. Just a few drops of blood, which can be taken from the fingertip or the heel, are sufficient to perform a DBS analysis.
  • the DS sample carrier preferably has at least three, preferably four, preferably circular, marked regions.
  • the blood drops are applied manually by lancet, pipette etc. in these circularly marked areas on the sample carrier and in a defined amount, which ensures that the blood is distributed homogeneously in the area defined by dashes.
  • the admission can take place directly at the place of sampling.
  • the DBS sample holder can be analyzed immediately. Due to the homogeneous distribution of the constituents and ingredients within the blood drop, it is possible to extract and examine a likewise defined blood volume by punching out a disc of defined diameter from the DBS sample carrier. The same applies to other homogeneous analysis fluids, such as urine and saliva or suitable solutions of substance samples.
  • the DS sample carrier is made of cellulose.
  • other materials e.g. a polymer-based DS sample carrier will be used which will fulfill certain functionalities, such as the ability to precipitate proteins.
  • the DS sample carrier is designed in the form of a cellulose card or a filter paper.
  • the DS sample carrier is at least partially closed by a non-detachably connected to the carrier plate cover layer, which cover layer has at least one opening in the region of the marked areas, which is closed by a detachable cover. This prevents contamination of the DS slide before use. Before placing a sample on the DS slide, the removable cover can be removed.
  • the detachable cover is limited by a perforation line introduced in the cover layer.
  • the release of the DS slide takes place here by separating the cover along the perforation line.
  • At least one test strip receptacle is at least partially closed by a cover layer which is not detachably connected to the carrier plate, which cover layer has a control window in the region of the test section of the test strip of the at least one test strip receptacle, wherein the cover layer has a sample feed window arranged at a distance from the control window allows a sample task on the sample receiving portion of at least one test strip.
  • each a test strip receiving test strip recordings are arranged, which open at one end in a common reservoir in which the sample receiving portions of the test strips are arranged and the sample application window of the cover layer is positioned.
  • the carrier plate is made of cardboard, wherein existing test strip receptacles and / or reservoirs and / or sample carrier recordings are formed by indentations. As a result, an environmentally friendly disposal of the device is achieved.
  • existing test strip receptacles and / or reservoirs and / or sample carrier receptacles can also be formed by recesses of an intermediate layer arranged between cover film and carrier plate.
  • the cover layer is formed from a film, which preferably substantially flat with the carrier plate and the carrier plate recorded test strips and DS sample carriers is partially bonded. This protects the test strips and the DS sample carriers from contamination.
  • the film is advantageously made of decomposable material.
  • the at least one control window is advantageously formed by a respective transparent region of the film.
  • two pivotally interconnected support plates are arranged, wherein a support plate is provided with at least one test strip receptacle and the voltage applied to this other support plate with at least one sample carrier receptacle.
  • the at least one test strip receptacle and the at least one sample carrier receptacle are preferably arranged on one half of the surface of a carrier plate such that in the folded-in state the half of a carrier plate provided with test strip receptacles rests against the half of the other carrier plate bearing no sample carrier receptacle.
  • At least one reservoir and / or a sample carrier receptacle is at least partially bordered by punctiform or linear elevations emerging from the carrier plate.
  • punctiform or linear elevations emerging from the carrier plate As a result, the surface tension of the surrounding areas is increased during filling, so that overflow of the liquid to be applied is prevented.
  • the surveys are preferred as punctiform nipples, as they are used in Braille, executed.
  • the selected as an embodiment device for targeted testing and display of the absence or presence of analytes in a liquid sample consists essentially of two along its longitudinal axis pivotally interconnected support plates 1, on each of which an intermediate layer 2 is applied, the two test strips 3 and receives a DS sample carrier 5 and which is provided with a cover layer 4.
  • the support plates 1 are made in the embodiment of cardboard and formed from a single centrally provided with a buckling fold 11 carton blank.
  • the intermediate layer 2 is made in the embodiment of corrugated cardboard and coated with a transparent, liquid-tight film to prevent ingress of sample liquid into the carton.
  • the intermediate layer 2 may also be provided with a waterproof, preferably environmentally friendly lacquer.
  • a recess 21 is introduced, are formed by the respective two test strip receptacles 12, which open into a reservoir 13.
  • the test strip receptacles 12 receive the test strips 3.
  • a second recess 22 is present in the intermediate layer, through which a sample carrier receptacle 14 is formed, which receives the DS sample carrier 5.
  • the test strip 3 is in FIG. 3 shown in step-by-step.
  • the test strip 3 has a carrier film 31, on which at one end a sample receiving section 32 is arranged.
  • an antibody coating 33 which contains antibodies which are conjugated with gold particles and which match an analyte to be detected or to an antigen of this analyte and can enter into an immunological reaction.
  • the antibody coating portion 33 is followed by a test portion 34 which is in the form of a membrane spaced from each other by a test line 341 and a control line 342 formed by and contained in an antigen contained in a reagent for the detection of a particular analyte Task of a sample are invisible.
  • the sample receiving section 32 of the test strip 3 is located below the sample application window 42 and the test section 34 is located below the control window 41 of the cover layer 4 applied to the intermediate layer 2.
  • test line 341 indicates the result of the test; the control line 342 indicates whether a sufficient amount of sample has been given, that is, whether the test is valid.
  • an absorber section 35 is arranged on the test strip 3.
  • the DS sample carrier 5 is in the form of a cellulose card, which is provided with three circularly marked sample application areas 15. Furthermore, the DS sample carrier 5 has two cross-shaped positioning markings 16. The positioning marks 16 are used for the positionally correct feeding of the DS sample carrier 5 to a punching device, by means of which a disc of defined diameter can be punched out of the DS sample carrier 5.
  • the cover layer 4 is formed in the embodiment of a rotting, colored film, which is provided with transparent, clear, low-reflection control windows 41. Spaced to the control windows 41, a sample application window 42 is arranged, which is formed by a recess introduced in the cover layer 4.
  • the sample feed window 42 is arranged in such a way that it is positioned over the sample receiving portions 32 of both test strips 3.
  • a sample receiving fleece (not shown) is arranged between the test strips 3 and the sample application window 42 of the cover layer 4, covering the sample receiving sections 32 of the two test strips 3.
  • a recess 43 is arranged in the cover layer 4, which allows access to the DS sample carrier 5.
  • the recess 43 is closed in the embodiment via a - not shown - releasable cover.
  • test section 34 Before performing a test, no lines 341, 342 are visible.
  • a sample volume of a sample liquid is applied to the sample receiving portion 32 of each test strip 3 through a sample application window 42 of the cover layer 4.
  • the sample liquid flows in the direction of test section 34. It first comes into contact with the antibody coating section 33 in which antibodies conjugated to gold particles are in an standardized (metered) amount for the antigen of an analyte to be detected.
  • the antibodies have different binding activity for different analytes (drugs).
  • the antibodies conjugated with gold particles are carried along by the sample liquid which flows through the test section 34.
  • the antigens of the analyte located there in the region of the test line 341 will bind the antibodies entrained by the sample fluid when flowing through the test section 34. Thereupon, a visible test line 341 is formed, which is given a red or brown color by the gold particles conjugated with the antibodies. The test result is negative.
  • test line 341 indicates if the test is valid. In FIG. 3 If the test line 341 is colored, the test is negative with respect to the corresponding analyte.
  • a small amount of further biological material for example blood, urine or saliva
  • a confirmation analysis can be carried out with the biological or other material deposited in the sample application areas 15, for example with the aid of liquid (liquid) chromatography tandem mass spectrometry (LC-MS / MS).
  • LC-MS / MS liquid chromatography tandem mass spectrometry
  • the device according to the invention is distinguished by the fact that, in a compact embodiment, it enables both a test of a large number of analytes and, at the same time, the deposition of further biological material, in particular blood, urine, saliva or other liquid samples to be analyzed.
  • the device according to the invention can thus be provided within the framework of a test with all the samples required for a confirmation analysis. In this case, the samples taken by the sample application areas 15 are subsequently no longer changeable.

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Claims (14)

  1. Dispositif de contrôle et d'affichage de la présence ou de l'absence d'analytes dans un échantillon d'analyse ou de liquides provenant de l'organisme humain ou d'un organisme animal, comprenant une plaque support avec au moins un réceptacle pour bandelette réactive dans lequel est disposée une bandelette réactive présentant un segment de réception de l'échantillon et un segment de test, caractérisé en ce que la plaque support comprend au moins un logement support (14) d'échantillon à distance du réceptacle (12) de bandelette réactive, sachant que le dispositif contient en outre un support d'échantillon « dried spot » (support d'échantillon DS) (5) qui est logé dans le logement support (14) d'échantillon.
  2. Dispositif selon la revendication 1, caractérisé en ce que le support d'échantillon DS (5) présente au moins trois, de préférence quatre, zones d'application (15) de l'échantillon configurées de préférence circulaires.
  3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que le support d'échantillon DS (5) est fabriqué en cellulose.
  4. Dispositif selon la revendication 3, caractérisé en ce que le support d'échantillon DS (5) est configuré en forme de papier filtre.
  5. Dispositif selon l'une des revendications 2 à 4, caractérisé en ce que le support d'échantillon DS (5) est obturé au moins localement au moyen d'une couche de couverture (4) reliée de manière non détachable avec la plaque support (1), laquelle couche de couverture (4) présente au moins un évidement (43) dans l'espace des zones (15) d'application de l'échantillon, évidement qui est obturé au moyen d'un couvercle détachable.
  6. Dispositif selon la revendication 5, caractérisé en ce que le couvercle détachable est limité par une ligne de perforation ménagée dans la couche de couverture (4).
  7. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'au moins un réceptacle (12) de bandelette réactive est obturé au moins localement via une couche de couverture (4) reliée de manière non détachable à la plaque support (1), laquelle couche de couverture (4) présente une fenêtre de contrôle (41) dans la zone du segment de test (34) de la bandelette réactive (3) d'au moins un réceptacle (12) de bandelette réactive, sachant que la couche de couverture (4) présente, à distance de la fenêtre de contrôle (41), une fenêtre (42) d'application de l'échantillon permettant d'appliquer l'échantillon sur le segment (32) recevant l'échantillon d'au moins une bandelette réactive (3).
  8. Dispositif selon la revendication 7, caractérisé en ce que sont disposés réciproquement parallèles au moins deux réceptacles (12) pour bandelettes réactives recevant chacun une bandelette réactive (3), réceptacles qui à une extrémité aboutissent dans un réservoir commun (13) dans lequel sont disposés les segments (32), recevant l'échantillon, des bandelettes réactives (3) et au-dessus duquel est positionnée la fenêtre (42), d'application de l'échantillon, de la couche de couverture (4).
  9. Dispositif selon l'une des revendications précédentes, caractérisé en ce que la plaque support (1) est fabriquée en carton, sachant que des réceptacles (12) pour bandelettes réactives et/ou des réservoirs (13) et/ou des logements (14) supports d'échantillon présents sont formés par des gaufrages.
  10. Dispositif selon l'une des revendications 1 à 8, caractérisé en ce que des réceptacles (12) pour bandelettes réactives et/ou des réservoirs (13) et/ou des logements (14) supports d'échantillons présents sont formés par des évidements (21) dans une couche intermédiaire (2) disposée entre la feuille de couverture (4) et la plaque support (1).
  11. Dispositif selon l'une des revendications précédentes, caractérisé en ce que la couche de couverture (4) est formée par un film qui de préférence est collé à plat contre la plaque support (1) et les bandelettes réactives (3) reçues par la plaque support (1) et qui est collé sur le support d'échantillon DS (Dried spot) (5).
  12. Dispositif selon l'une des revendications précédentes, caractérisé en ce que sont disposées deux plaques supports (1) reliées l'une à l'autre de manière pivotante, sachant qu'une plaque support est munie d'au moins un réceptacle (12) pour bandelette réactive et que l'autre plaque support (1) appliquant contre celui-ci est munie d'au moins un logement (14) support d'échantillon.
  13. Dispositif selon la revendication 12, caractérisé en ce qu'au moins un réceptacle (12) pour bandelette réactive ainsi qu'au moins un logement (14) support d'échantillon sont disposés chacun sur une moitié de la surface d'une plaque support (1), de sorte qu'à l'état replié la moitié respective, munie des réceptacles (12) pour bandelettes réactives, d'une plaque support (1) applique contre la moitié, ne présentant pas de logement (14) support d'échantillon, de l'autre plaque support (1) appliquant contre celle-ci.
  14. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'au moins un réservoir (13) et/ou un logement (14) support d'échantillon est entouré au moins localement de protubérances en pointillés et/ou linéaires dépassant de la plaque support (1).
EP17155143.5A 2017-02-08 2017-02-08 Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide Active EP3361253B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP17155143.5A EP3361253B1 (fr) 2017-02-08 2017-02-08 Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide
PCT/EP2018/050264 WO2018145830A1 (fr) 2017-02-08 2018-01-05 Dispositif de contrôle ciblé et d'affichage de l'absence ou de la présence d'analytes dans un échantillon liquide

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP17155143.5A EP3361253B1 (fr) 2017-02-08 2017-02-08 Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide

Publications (2)

Publication Number Publication Date
EP3361253A1 EP3361253A1 (fr) 2018-08-15
EP3361253B1 true EP3361253B1 (fr) 2019-12-04

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EP17155143.5A Active EP3361253B1 (fr) 2017-02-08 2017-02-08 Dispositif de contrôle ciblé et d'affichage de la présence ou de l'absence d'analytes dans un échantillon liquide

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EP (1) EP3361253B1 (fr)
WO (1) WO2018145830A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3745131B1 (fr) 2019-05-29 2022-03-30 Protzek Gesellschaft für Biomedizinische Technik GmbH Procédé et moyen de prolongation du temps d'évaluation d'une bande d'essai destinée à la détection visuelle des analytes
DE202020102077U1 (de) * 2020-04-15 2020-05-11 Protzek Gesellschaft für Biomedizinische Technik GmbH Vorrichtung zur gezielten Prüfung auf eine erfolgte Infektion mit dem Coronavirus-SARS-CoV-2

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080299010A1 (en) * 2007-05-30 2008-12-04 Ally Shivji Biological specimen collection card
EP2420831A1 (fr) * 2010-08-20 2012-02-22 Agilent Technologies, Inc. Dispositif et méthode pour éprouver des tâches de sang sèches

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070092401A1 (en) * 2005-10-26 2007-04-26 Feier Liao Devices and methods for sample collection and analysis
US20140072959A1 (en) * 2012-09-12 2014-03-13 Force Diagnostics, Inc. Rapid tests for insurance underwriting
DE202014002369U1 (de) 2013-03-23 2014-04-29 Ingenieurbüro Protzek & Kollegen Gbr(Vertreten Durch Den Gesellschafter: Christoph Protzek,79539 Lörrach) Gerät zum Nachweis von Analyten in einer flüssigen Probe
US20160116489A1 (en) * 2014-10-23 2016-04-28 Biomedomics, Inc. Lateral flow immunoassay method of simultaneously detecting hemoglobin s, hemoglobin c, and hemoglobin a in newborns, infants, children, and adults
DE202016104645U1 (de) 2016-08-24 2016-10-04 Protzek Gesellschaft für Biomedizinische Technik GmbH Vorrichtung zum visuellen Nachweis von Analyten in einer flüssigen Probe

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080299010A1 (en) * 2007-05-30 2008-12-04 Ally Shivji Biological specimen collection card
EP2420831A1 (fr) * 2010-08-20 2012-02-22 Agilent Technologies, Inc. Dispositif et méthode pour éprouver des tâches de sang sèches

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EP3361253A1 (fr) 2018-08-15

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